Nyrén O, McLaughlin J K, Yin L, Josefsson S, Engqvist M, Hakelius L, Blot W J, Adami H O
Department of Medical Epidemiology, Karolinska Institutet, Stockholm, Sweden.
Neurology. 1998 Apr;50(4):956-61. doi: 10.1212/wnl.50.4.956.
To examine the risk of neurologic disorders among women with breast implants.
Case reports in the literature have raised concern about a possible link between silicone breast implants and some types of neurologic disorders, but there is a dearth of epidemiologic studies in this area.
Through the nationwide Swedish hospital discharge register, we identified a population-based cohort of 7433 women with breast implants. A similarly identified cohort of 3351 women who underwent breast reduction surgery served as a comparison. The women were followed from 1972 (or date of breast surgery if it occurred later) through 1993 by means of record linkages and review of inpatient medical records. Ratios of observed to expected numbers, and relative risks (RR) with 95% confidence intervals (CI), were calculated as measures of the risk of neurologic diseases among women with implants.
A direct comparison of the exposed (implant) versus comparison (breast reduction) groups, after exclusion of patients with pre-existing disease or incorrect neurologic diagnoses, showed no excess risk among implant patients (RR = 0.8; 95% CI = 0.5 to 1.4). When external rates derived from the background population were used as comparison, we found a small, statistically nonsignificant excess of neurologic disorders both in the breast implant (RR = 1.3; 95% CI = 0.9 to 1.9) and the breast reduction (RR = 1.5; 95% CI = 0.9 to 2.4) cohorts.
Our results provide no support for the conjecture that breast implants cause neurologic disease.
研究植入乳房假体的女性患神经疾病的风险。
文献中的病例报告引发了人们对硅胶乳房假体与某些类型神经疾病之间可能存在联系的担忧,但该领域缺乏流行病学研究。
通过瑞典全国医院出院登记系统,我们确定了一个基于人群的队列,其中包括7433名植入乳房假体的女性。另外确定了一个由3351名接受过乳房缩小手术的女性组成的队列作为对照。通过记录链接和查阅住院病历,对这些女性从1972年(或乳房手术日期,若手术时间更晚)至1993年进行随访。计算观察数与预期数的比值以及相对风险(RR)和95%置信区间(CI),以此作为植入假体女性患神经疾病风险的衡量指标。
在排除已有疾病或神经诊断错误的患者后,对暴露组(植入假体)与对照组(乳房缩小手术组)进行直接比较,结果显示植入假体的患者没有额外风险(RR = 0.8;95% CI = 0.5至1.4)。当以背景人群的外部发病率作为对照时,我们发现乳房植入假体队列(RR = 1.3;95% CI = 0.9至1.9)和乳房缩小手术队列(RR = 1.5;95% CI = 0.9至2.4)中神经疾病的发生率均有小幅增加,但在统计学上无显著意义。
我们的研究结果不支持乳房假体导致神经疾病这一推测。